Staff Scientist, Immunoassay Development

The role

The Staff Scientist provides scientific and strategic leadership for the development, qualification, characterization, and lifecycle management of critical reagents and reference materials. This individual will develop new immunoassays and evaluate innovative platforms to support the vaccine pipeline.

What you will do

• Serve as a senior technical expert and individual contributor for immunoassay development.
• Lead and execute complex laboratory studies for assay development, optimization, and validation readiness.
• Develop new fit-for-purpose immunoassays for potency, antigenicity, identity, impurity, and stability.
• Provide scientific leadership for assay design, including format selection and reagent strategy.
• Evaluate innovative immunoassay platforms including ELISA, MSD, and multiplex assays.
• Troubleshoot immunoassay performance trends using data-driven experimental approaches.
• Interpret complex immunoassay data including standard curves, precision, and specificity.
• Contribute to immunoassay analytical control strategies.
• Support routine testing within the CMC Immunoassay group.
• Provide technical guidance to scientists and research associates.

Required qualifications

• PhD in Biochemistry, Immunology, Analytical Chemistry, Biological Sciences, or a related discipline with a minimum of 8 years of relevant biopharmaceutical industry experience; or
• M.S. in a related discipline with a minimum of 13 years of relevant biopharmaceutical industry experience; or
• B.S. in a related discipline with a minimum of 16 years of relevant biopharmaceutical industry experience.
• Significant hands-on, lab-based experience developing, optimizing, troubleshooting, and executing immunoassays in vaccine CMC, biologics analytical development, QC, ASAT, or other regulated analytical
• Demonstrated scientific depth in immunoassay method development.
• Strong technical experience with ligand-binding immunoassay platforms such as ELISA, MSD, electrochemiluminescence-based assays, bead-based assays, or multiplex assays.
• Ability to independently design experiments, interpret complex data, and troubleshoot assay performance.
• Experience evaluating innovative immunoassay platforms.
• Experience supporting potency, antigenicity, identity, impurity, characterization, comparability, release, stability, process development, method transfer, validation-support, routine testing, or regu
• Experience contributing to immunoassay control strategies.
• Ability to mentor junior scientists and influence technical direction.
• Strong written and verbal communication skills.

Nice to have

• Experience supporting outsourced immunoassay activities with CROs, CDMOs, contract testing laboratories, reagent vendors, or technology partners
• Experience working in or supporting GMP-regulated analytical environments
• Hands-on experience with MSD platforms
• Hands-on experience with multiplex or other multiplex immunoassay platforms
• Direct experience with conjugated vaccines, polysaccharide-protein conjugates, multivalent vaccines, or other complex biologics
• Experience supporting late-stage development, PPQ readiness, BLA preparation, commercial readiness, or lifecycle management of vaccine or biologics programs
• Experience contributing to regulatory submissions, health authority responses, technical reports, method development reports, or validation-support documentation
• Experience with automation, high-throughput immunoassay workflows, multiplex assay design, LIMS, ELN, and digital data analysis tools
• Experience helping build or scale analytical capabilities or technical platforms within a growing organization

Benefits

• Comprehensive benefits
• Equity component

About the company

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases.